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ACHRE Report

Final Report

Executive Summary

Preface

Introduction

Part I

Part II

Part III

Discussion: Part III

Part IV

Part I: Overview

When the Advisory Committee began work in April 1994 we were charged with determining whether "the [radiation] experiments' design and administration adequately met the ethical and scientific standards, including standards of informed consent, that prevailed at the time of the experiments and that exist today" and also to "determine the ethical and scientific standards and criteria by which it shall evaluate human radiation experiments."

Although this charge seems straightforward, it is in fact difficult to determine what the appropriate standards should be for evaluating the conduct and policies of thirty or fifty years ago. First, we needed to determine the extent to which the standards of that time are similar to the standards of today. To the extent that there were differences we needed to determine the relative roles of each in making moral evaluations.

In chapter 1 we report what we have been able to reconstruct about government rules and policies in the 1940s and 1950s regarding human experiments. We focus primarily on the Atomic Energy Commission and the Department of Defense, because their history with respect to human subjects research policy is less well known than that of the Department of Health, Education, and Welfare (now the Department of Health and Human Services). Drawing on records that were previously obscure, or only recently declassified, we reveal the perhaps surprising finding that officials and experts in the highest reaches of the AEC and DOD discussed requirements for human experiments in the first years of the Cold War. We also briefly discuss the research policies of DHEW and the Veterans Administration during these years.

In chapter 2 we turn from a consideration of government standards to an exploration of the norms and practices of physicians and medical scientists who conducted research with human subjects during this period. We include here an analysis of the significance of the Nuremberg Code, which arose out of the international war crimes trial of German physicians in 1947. Using the results of our Ethics Oral History Project, and other sources, we also examine how scientists of the time viewed their moral responsibilities to human subjects as well as how this translated into the manner in which they conducted their research. Of particular interest are the differences in professional norms and practices between research in which patients are used as subjects and research involving so-called healthy volunteers.

In chapter 3 we return to the question of government standards, focusing now on the 1960s and 1970s. In the first part of this chapter, we review the well-documented developments that influenced and led up to two landmark events in the history of government policy on research involving human subjects: the promulgation by DHEW of comprehensive regulations for oversight of human subjects research and passage by Congress of the National Research Act. In the latter part of the chapter we review developments and policies governing human research in agencies other than DHEW, a history that has received comparatively little scholarly attention. We also discuss scandals in human research conducted by the DOD and the CIA that came to light in the 1970s and that influenced subsequent agency policies.

With the historical context established in chapters 1 through 3, we turn in chapter 4 to the core of our charge. Here we put forward and defend three kinds of ethical standards for evaluating human radiation experiments conducted from 1944 to 1974. We embed these standards in a moral framework intended to clarify and facilitate the difficult task of making judgments about the past.

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